Diagnosing and performing interventional procedures on tissue in vivo
A catheter for diagnosing and performing an interventional procedure on tissue has an elongated catheter shaft, and optical fibers, extending through the catheter shaft, for transmitting light to tissue located at a distal end of the catheter and conveying light back from the tissue for analysis by a spectroscopic diagnosis system to determine whether an interventional procedure should be performed on the tissue. An interventional device is located at the distal end of the catheter for engaging tissue diagnosed by the spectroscopic diagnosis system in order to perform the interventional procedure on the tissue. An assembly for imaging and performing an interventional procedure on tissue has an endoscope in combination with an endoscopically insertable catheter having an ultrasound imaging device for imaging a tissue structure located at a distal end of the endoscope so as to enable the depth of penetration of the tissue structure to be displayed, and an endoscopically insertable interventional device for engaging the tissue structure imaged by the ultrasound imaging device.
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This application relates to diagnosing and performing interventional procedures on tissue using endoscopically insertable catheters.
Lesions in body lumens such as the alimentary track may be diagnosed by inserting an endoscope into the alimentary track and inserting through a working channel of the endoscope a catheter having optical fibers for transmitting light to tissue located at a distal end of the catheter and for conveying light back from the tissue for analysis by a spectroscopic diagnosis system. If the spectroscopic diagnosis system determines an interventional procedure should be performed on the tissue, a biopsy of the tissue may be taken or the tissue may be otherwise removed or treated.
SUMMARY OF THE INVENTIONOne aspect of the invention features a catheter for diagnosing and performing an interventional procedure on tissue. The catheter has an elongated catheter shaft, and optical fibers, extending through the catheter shaft, transmit light to tissue located at a distal end of the catheter shaft and convey light back from the tissue for analysis by a spectroscopic diagnosis system to determine whether an interventional procedure should be performed on the tissue. An interventional device is located at the distal end of the catheter shaft for engaging tissue diagnosed by the spectroscopic diagnosis system in order to perform the interventional procedure on the tissue.
In various embodiments the catheter is constructed to be inserted through the working channel of an endoscope, and the interventional device is, for example, a scalpel, forceps jaws, a snare, a scissors, or a needle. An interventional needle can be used, for example, to cut the tissue, to apply an adhesive material to the tissue, to inject a chemical ablation fluid into the tissue, or to inject a marking fluid into the tissue so as to enable the tissue to be treated by another interventional device, which may be located on another catheter. Because the interventional device is located on the same catheter as the optical fibers, the physician can perform the interventional procedure on the tissue without having to remove the catheter from the patient's body. Moreover, the diagnosis and interventional procedure can be accomplished at multiple sites without having to remove the catheter from the patient's body. In various embodiments the interventional device is, for example, a scalpel, forceps jaws, a snare, a scissors, or a needle.
Another aspect of the invention features an assembly comprising an endoscope, a catheter shaft insertable through a working channel of the endoscope having optical fibers for transmitting light to tissue and from tissue for analysis by a spectroscopic diagnosis system to determine whether an interventional procedure should be performed on the tissue, and an interventional device, insertable through a working channel of the endoscope, for performing the interventional procedure on the tissue.
Another aspect of the invention features a method for imaging and performing an interventional procedure on tissue. A catheter having an ultrasound imaging device located at its distal end is inserted through a working channel of an endoscope, for imaging a tissue structure located at a distal end of the endoscope, and the tissue structure is displayed in a manner that indicates-the depth of penetration of the tissue structure into the body of the living being. An interventional device, which is inserted through a working channel of the endoscope, performs interventional therapy on the tissue structure in a manner responsive to the displayed depth of penetration of the tissue structure.
This aspect of the invention enables the physician to determine the depth to which a tumor has grown into or through the wall of a lumen in order to determine whether the tumor can be removed safely from the lumen. The physician can rely on the ultrasound image display to determine how much tissue to remove in view of the depth of penetration of the tissue structure, and can also observe the ultrasound image of the tissue structure while performing the interventional procedure on the tissue structure so as to ensure that an appropriate amount of tissue is removed.
In general, the invention aids physicians in the accurate early diagnosis of patients with cancer or other abnormalities inside the body. Many cancers or other abnormalities can be treated efficiently if diagnosed and treated early enough in the least invasive manner. The invention helps physicians to locate suspect areas, diagnose accurately, and sample and treat tissue efficiently. The invention also provides high diagnostic accuracy and short procedural time by providing accurate data and avoiding unnecessary biopsies. Consequently, overall health care costs are low because of low lab analysis costs and minimal outpatient hospital visits.
Numerous other features, objects, and advantages of the invention will become apparent from the following detailed description when read in connection with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
With reference to
With reference to
With reference to
For example, optical fiber 38 transmits a monochromatic light beam having a wavelength or set of wavelengths selected to cause the tissue to fluoresce in a manner such that at one wavelength of the fluorescent light the intensity is approximately the same regardless of whether the tissue is normal or cancerous and at another wavelength of the fluorescent light the intensity differs substantially depending on whether the tissue is normal or cancerous. By analyzing the ratio of the intensity of the fluorescent light at the wavelength at which the intensity is approximately the same regardless of whether the tissue is normal or cancerous to the intensity of the fluorescent light at the wavelength at which the intensity differs substantially depending whether the tissue is normal or cancerous, spectroscopic diagnosis system 42 can determine whether the tissue is normal or cancerous, and in some instances whether the tissue is a benign tumor. The tissue may first be treated by a diagnostic reagent that bonds more selectively with diseased (cancerous) tissue than with normal tissue, or vice versa, and that absorbs light transmitted through the catheter and thereby causes the tissue to fluoresce at a wavelength or set of wavelengths different from the transmission wavelength. The intensity of the light conveyed back to the spectroscopic diagnosis system may be displayed graphically through the aid of a computer as a function of wavelength, and the endoscopist can interpret the data.
Referring to
Optical fiber 38 transmits light to the tissue at a number of points and optical fiber 40 conveys light back from the tissue for analysis by spectroscopic diagnosis system 42 in order to determine whether the tissue is cancerous at each of these points. Each such point that is determined to be cancerous is marked by india ink 48 using needle 44.
With reference to
Numerous other embodiments are also within the scope of the claims. For example,
In
In
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In
Each of the embodiments described above in connection with
With reference to
Endoscope 200 has an optical fiber 202 for transmitting light from light source 230 to tissue located at a distal end of endoscope 200, an optical fiber 204 for conveying light back from the tissue to eyepiece 234 for viewing tissue, a fluid channel 206 for flushing tissue with fluid provided by fluid source 232, and working channels 208, 210 for receiving catheters 212 and 216 respectively. Interventional catheter control mechanism 224 controls the longitudinal movement of catheter 216 within working channel 210 as well as the operation of forceps jaws 218.
Similarly, ultrasound catheter control mechanism 226 controls the longitudinal movement of ultrasound catheter 212 within working channel 208 as well as the operation of ultrasound transducer 214, including its rotation, transmission of ultrasound pulses, and detection of reflected pulses by the transducer. The ultrasound image of the tissue imaged by the ultrasound transducer is displayed by ultrasound image display 228.
The endoscope of
For example, in
If the tissue is found to be cancerous or otherwise in need of removal, ultrasound imaging catheter 214 is used to measure the depth to which a tumor has grown into or through the wall of a lumen to determine whether the tumor can be removed safely from the lumen. If the cancerous tissue imaged by ultrasound imaging device 214 can be removed safely from the lumen, forceps jaws 218 are used to remove the cancerous tissue. After forceps jaws 218 remove the cancerous tissue, optical fibers 220, 222 are used to perform spectroscopic diagnosis on the tissue to determine whether all of the cancerous tissue has been removed.
There have been described novel and improved apparatus and techniques for diagnosing and performing interventional procedures on tissue. It is evident that those skilled in the art may now make numerous uses and modifications of and departures from the specific embodiments described herein without departing from the inventive concept. For example, other interventional devices may be substituted for the ones described above and set forth in the drawings.
Claims
1-51. (canceled)
52. A system for diagnosing and treating tissue, comprising:
- an endoscope;
- an elongated catheter shaft defining at least two lumens and including a distal end that is insertable into a lumen of the endoscope;
- a first optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for transmitting light to tissue located at a distal end of the catheter shaft;
- a second optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for conveying light back from the tissue for analysis by a spectroscopic diagnosis system to determine whether an interventional procedure should be performed on the tissue, wherein said second optical fiber and said first optical fiber are discrete fibers and at least one of the fibers includes a viewing device for converting a second conveyed light back from the tissue into a visual observation image of the tissue;
- a rotatable ultrasonic transducer for determining a depth at which an interventional procedure is to be performed; and
- an interventional device located at the distal end of the catheter shaft for engaging tissue diagnosed by the spectroscopic diagnosis system in order to perform the interventional procedure on the tissue, wherein said interventional device is physically separable from said first and second optical fibers.
53. The catheter of claim 52, wherein the interventional device comprises a scalpel.
54. The catheter of claim 52, wherein the interventional device comprises forceps jaws.
55. The catheter of claim 52, wherein the interventional device comprises a snare.
56. The catheter of claim 52, wherein the interventional device comprises a scissors.
57. The catheter of claim 52, wherein the interventional device comprises a needle.
58. The catheter of claim 57, wherein the needle is constructed to inject a marking fluid into the tissue.
59. The catheter of claim 57, wherein the needle is constructed to inject a chemical ablation fluid into the tissue.
60. The catheter of claim 57, wherein the needle is constructed to cut the tissue.
61. The catheter of claim 57, wherein the needle is constructed to apply an adhesive material to the tissue.
62. The catheter of claim 57, wherein the needle is constructed to convey a fluid to the tissue useful for enabling visual observation of the tissue.
63. The catheter of claim 57, wherein the needle is constructed to apply a vacuum to the tissue.
64. The catheter of claim 52, wherein the catheter shaft is constructed to be inserted through the working channel of an endoscope.
65. The catheter of claim 52, wherein at least one of the optical fibers is further constructed for conveying visualization light to the tissue.
66. A method of diagnosing and performing an interventional procedure on tissue, comprising the steps of:
- inserting an endoscope into a patient's body;
- inserting a catheter into a lumen of the endoscope, the catheter having an elongated shaft defining at least two lumens and including a distal end, a first optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for transmitting light to tissue located a the distal end of the catheter, a second optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for conveying light back from the tissue for analysis by a spectroscopic diagnosis system, and an interventional device, wherein said first optical fiber and said second optical fiber are discrete fibers, and said interventional device is physically separable from said first and second optical fibers;
- transmitting light through the first optical fiber to tissue located at the distal end of the catheter;
- conveying light back from the tissue through the second optical fiber for analysis by a spectroscopic diagnosis system;
- conveying light back from the tissue through at least one of the first or second optical fibers for visual observation of the tissue;
- diagnosing the tissue with the spectroscopic diagnosis system to determine whether an interventional procedure should be performed on the tissue;
- delivering a rotatable ultrasonic imaging device through a lumen of the endoscope to determine a depth to which an interventional procedure should be performed on the tissue; and
- engaging, with the interventional device, the tissue diagnosed by the spectroscopic diagnosis system in order to perform the interventional procedure on the tissue.
67. The method of claim 66, wherein the interventional procedure comprises marking the tissue by injecting a marking fluid into the tissue with the interventional device.
68. The method of claim 67, wherein the marking fluid is India ink.
69. The method of claim 67, further comprising the steps of:
- withdrawing the catheter having the optical fibers and the interventional device; inserting into the body of the living being a second catheter having a second interventional device located at its distal end; and engaging, with the second interventional device of the second catheter, the tissue diagnosed by the spectroscopic diagnosis system in order to perform another interventional procedure on the tissue.
70. The method of claim 66, wherein the step of diagnosing the tissue using the spectroscopic diagnosis system comprises determining whether an interventional procedure should be performed on the tissue.
71. The method of claim 66, wherein the interventional procedure comprises removing tissue for biopsy analysis.
72. The method of claim 66, wherein the interventional procedure comprises removing tissue diagnosed by the spectroscopic diagnosis system as being unhealthy.
73. The method of claim 66, wherein the lumen comprises an alimentary lumen.
74. The method of claim 66, wherein the lumen comprises a pulmonary lumen.
75. The method of claim 66, wherein the step of diagnosing the tissue further comprises determining whether the tissue is a tumor.
76. The method of claim 75, wherein the step of diagnosing the tissue further comprises determining whether the tumor is cancerous.
77. The method of claim 66, further comprising the step of inserting through the lumen of the body of the living being an endoscope having a working channel, and wherein the step of inserting the catheter into the body of the living being comprises inserting the catheter into the working channel of the endoscope.
78. The method of claim 66, further comprising the step of conveying visualization light to the tissue through at least one of the optical fibers.
79. The method of claim 66, further comprising the step of conveying a fluid through the catheter shaft to the tissue useful for enabling visual observation of the tissue.
80. The method of claim 66, further comprising the step of applying a vacuum to the tissue through the catheter shaft.
81. An assembly comprising:
- an endoscope;
- an elongated catheter shaft defining at least two lumens and including a distal end, and constructed to be insertable through a working channel of the endoscope;
- a first optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for transmitting light to tissue located at the distal end of the catheter shaft;
- a second optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for conveying light back from the tissue for analysis by a spectroscopic diagnosis system to determine whether an interventional procedure should be performed on the tissue, wherein said second optical fiber and said first optical fiber are discrete fibers and at least one of the fibers includes a viewing device for converting a second conveyed light back from the tissue into a visual observation image of the tissue;
- an ultrasound transducer that is insertable into a channel of the endoscope to determine a depth for performing an interventional procedure on the tissue; and
- an interventional device, constructed to be insertable through a working channel of an endoscope, for engaging tissue diagnosed by the spectroscopic diagnosis system in order to perform the interventional procedure on the tissue, wherein said interventional device is physically separable from said first and second optical fibers.
82. The assembly of claim 81, wherein the interventional device is located at the distal end of the catheter shaft having the optical fibers.
83. A method of diagnosing and performing an interventional procedure on tissue, comprising the steps of:
- inserting an endoscope through a lumen of a body of a living being;
- inserting through a working channel of the endoscope a catheter having an elongated shaft defining at least two lumens and including a distal end, a first optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for transmitting light to tissue located at the distal end of the catheter, a second optical fiber, removably insertable into one of the at least two lumens of the catheter shaft and extendable beyond the distal end of the catheter shaft, for conveying light back from the tissue for analysis by a spectroscopic diagnosis system wherein said first optical fiber and said second optical fiber are discrete fibers;
- transmitting light through the first optical fiber to tissue located at the distal end of the catheter;
- conveying light back from the tissue through the second optical fiber for analysis by a spectroscopic diagnosis system;
- conveying light back from the tissue through at least one of the optical fibers for visual observation of the tissue;
- diagnosing the tissue with the spectroscopic diagnosis system to determine whether an interventional procedure should be performed on the tissue;
- inserting an ultrasound transducer into the endoscope to determine a depth at which the interventional procedure should be performed; and
- engaging, with an interventional device insertable through a working channel of the endoscope, the tissue diagnosed by the spectroscopic diagnosis system in order to perform the interventional procedure on the tissue, wherein said interventional device is physically separable from said first and second optical fibers.
Type: Application
Filed: Oct 3, 2005
Publication Date: Feb 16, 2006
Patent Grant number: 8135454
Applicant:
Inventors: Douglas Daniels (Mendon, MA), Michael Banik (Bolton, MA)
Application Number: 11/242,236
International Classification: A61B 6/00 (20060101);